Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

The use of contrast media (CM) poses a risk of post-contrast acute kidney injury (PC-AKI), especially among patients chronic kidney disease (CKD). International guidelines recommend intravenous (IV) hydration with isotonic 0.9% NaCl for three-four hours pre-contrast and four-six hours post-contrast. Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD (eGFR 30-60 mL/min/1.73 m2). However, no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD (eGFR \< 30 mL/min/1.73 m2).

Thus, the main focus of this trial is to evaluate IV hydration vs. oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD, who are scheduled for an elective contrast-enhanced CT-scan (CECT) with IV contrast-administration.

Our research hypotheses consist of the following:

1. Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 0.9% NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT. 2. NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI, dialysis, renal adverse events, hospitalization, progression in CKD-symptoms, and all-cause mortality.

Eligibility criteria

Qualifiers

eGFR < 30 mL/min/1.73 m2

Scheduled for elective IV CECT

Age ≥ 18

Signed informed consent

Disqualifiers

Allergy to Iodine

Pregnancy

Active dialysis treatment

Acute infectious or inflammatory disease

Trial design

Treatments tested in this trial

  • Preventive treatment with IV-hydration
  • Preventive treatment with oral hydration

Treatment groups

254 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Department of Nephrology, Odense University Hospital

Collaborator

Department of Clinical Genetics, Odense University Hospital

Collaborator

The A.P. Moller Foundation

Collaborator

The Research Counsil of Odense University Hospital

Collaborator

Copenhagen University's Research Foundation for Medical Students

Collaborator

Helen and Ejnar Bjørnow's Foundation

Collaborator

Novo Nordisk A/S

Collaborator

Sophus Jacobsen and Astrid Jacobsen's Foundation

Collaborator

Region of Southern Denmark

Collaborator